Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring, 61646-61648 [2018-26032]
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Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
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Jkt 247001
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, PROVAYBLUE
(methylene blue) indicated for the
treatment of pediatric and adult patients
with acquired methemoglobinemia.
Subsequent to this approval, the USPTO
received a patent term restoration
application for PROVAYBLUE (U.S.
Patent No. 8,765,942) from Provepharm
S.A.S. and the USPTO requested FDA’s
assistance in determining the patent’s
eligibility for patent term restoration. In
a letter dated February 6, 2018, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of PROVAYBLUE represented
the first permitted commercial
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
PROVAYBLUE is 415 days. Of this time,
232 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: February 20,
2015. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was February 20, 2015.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: October 9, 2015.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
PROVAYBLUE (NDA 204630) was
initially submitted on October 9, 2015.
3. The date the application was
approved: April 8, 2016. FDA has
verified the applicant’s claim that NDA
204630 was approved on April 8, 2016.
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This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 298 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26035 Filed 11–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0597]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Oversight of
Clinical Investigations: A Risk-Based
Approach to Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
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Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with oversight of
clinical investigations, a risk-based
approach to monitoring.
DATES: Submit either electronic or
written comments on the collection of
information by January 29, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 29,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 29, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
VerDate Sep<11>2014
17:00 Nov 29, 2018
Jkt 247001
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–D–0597 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Oversight
of Clinical Investigations: A Risk-Based
Approach to Monitoring.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
PO 00000
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Fmt 4703
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61647
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring—
21 CFR Parts 312 and 812
OMB Control Number 0910–0733—
Extension
This information collection supports
reporting and recordkeeping found in
Agency guidance. Under parts 312 and
812 (21 CFR parts 312 and 812),
sponsors are required to provide
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61648
Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
appropriate oversight of their clinical
investigations to ensure adequate
protection of the rights, welfare, and
safety of human subjects and to ensure
the quality and integrity of the resulting
data submitted to FDA. As part of this
oversight, sponsors of clinical
investigations are required to monitor
the conduct and progress of their
clinical investigations. The regulations
do not specify how sponsors are to
conduct monitoring of clinical
investigations and are, therefore,
compatible with a range of approaches
to monitoring.
Accordingly, we developed the
guidance document entitled, ‘‘Guidance
for Industry—Oversight of Clinical
Investigations: A Risk-Based Approach
to Monitoring.’’ The guidance is
intended to assist sponsors of clinical
investigations in developing strategies
for risk-based monitoring and plans for
clinical investigations of human drug
and biological products, medical
devices, and combinations thereof. The
guidance describes strategies for
monitoring activities performed by
sponsors or by contract research
organizations (CROs) that focus on the
conduct, oversight, and reporting of
findings of an investigation by clinical
investigators. The guidance also
recommends strategies that reflect a
risk-based approach to monitoring that
focuses on critical study parameters and
relies on a combination of monitoring
activities to oversee a study effectively.
Finally, the guidance specifically
encourages greater reliance on
centralized monitoring methods where
appropriate.
Information collections for reports
and records associated with clinical
investigations under parts 312 and 812
are currently approved under OMB
control numbers 0910–0014 and 0910–
0078 respectively. These reporting and
recordkeeping provisions cover general
elements. The guidance discusses other
elements sponsors and investigators
should consider and include in
developing a monitoring plan. As
explained in the guidance,
documentation of monitoring should
include sufficient detail to allow
verification that the monitoring plan
was followed. The plan should provide
adequate information to those involved
with monitoring to effectively carry out
their duties. All sponsor and CRO
personnel who may be involved with
monitoring (including those who review
appropriate action, determine
appropriate action, or both) regarding
potential issues identified through
monitoring should review the
monitoring plan.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Documentation included in comprehensive monitoring plan
1 There
Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26032 Filed 11–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES1
[Docket No. FDA–2013–D–1445]
1.5
Food and Drug Administration,
HHS.
Notice of availability.
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17:00 Nov 29, 2018
Jkt 247001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance for industry and FDA staff
entitled ‘‘Blood Glucose Monitoring
Test Systems for Prescription Point-ofCare Use.’’ This draft guidance
document describes studies and criteria
that FDA recommends be used when
submitting premarket notifications
(510(k)s) for blood glucose monitoring
systems (BGMSs) that are for
prescription point-of-care use. This draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by February 28, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care
Use; Draft Guidance for Industry and
Food and Drug Administration Staff;
Availability
ACTION:
88
Total Annual
Records
132
Average
burden per
recordkeeping
4
Total hours
528
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we have made no
adjustments to our burden estimate. We
estimate 88 sponsors will develop 132
comprehensive monitoring plans in
accordance with the guidance. We
believe the associated burden for each
plan is approximately 4 hours and
includes the time necessary to develop,
and amend as appropriate, the
monitoring plan.
AGENCY:
Number of
records per
recordkeeper
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61646-61648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26032]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0597]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Oversight of Clinical Investigations: A Risk-Based
Approach to Monitoring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public
[[Page 61647]]
comment on the proposed collection of certain information by the
Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on information collection associated with oversight
of clinical investigations, a risk-based approach to monitoring.
DATES: Submit either electronic or written comments on the collection
of information by January 29, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-D-0597 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Oversight of Clinical
Investigations: A Risk-Based Approach to Monitoring.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Oversight of Clinical Investigations: A Risk-Based Approach to
Monitoring--21 CFR Parts 312 and 812
OMB Control Number 0910-0733--Extension
This information collection supports reporting and recordkeeping
found in Agency guidance. Under parts 312 and 812 (21 CFR parts 312 and
812), sponsors are required to provide
[[Page 61648]]
appropriate oversight of their clinical investigations to ensure
adequate protection of the rights, welfare, and safety of human
subjects and to ensure the quality and integrity of the resulting data
submitted to FDA. As part of this oversight, sponsors of clinical
investigations are required to monitor the conduct and progress of
their clinical investigations. The regulations do not specify how
sponsors are to conduct monitoring of clinical investigations and are,
therefore, compatible with a range of approaches to monitoring.
Accordingly, we developed the guidance document entitled,
``Guidance for Industry--Oversight of Clinical Investigations: A Risk-
Based Approach to Monitoring.'' The guidance is intended to assist
sponsors of clinical investigations in developing strategies for risk-
based monitoring and plans for clinical investigations of human drug
and biological products, medical devices, and combinations thereof. The
guidance describes strategies for monitoring activities performed by
sponsors or by contract research organizations (CROs) that focus on the
conduct, oversight, and reporting of findings of an investigation by
clinical investigators. The guidance also recommends strategies that
reflect a risk-based approach to monitoring that focuses on critical
study parameters and relies on a combination of monitoring activities
to oversee a study effectively. Finally, the guidance specifically
encourages greater reliance on centralized monitoring methods where
appropriate.
Information collections for reports and records associated with
clinical investigations under parts 312 and 812 are currently approved
under OMB control numbers 0910-0014 and 0910-0078 respectively. These
reporting and recordkeeping provisions cover general elements. The
guidance discusses other elements sponsors and investigators should
consider and include in developing a monitoring plan. As explained in
the guidance, documentation of monitoring should include sufficient
detail to allow verification that the monitoring plan was followed. The
plan should provide adequate information to those involved with
monitoring to effectively carry out their duties. All sponsor and CRO
personnel who may be involved with monitoring (including those who
review appropriate action, determine appropriate action, or both)
regarding potential issues identified through monitoring should review
the monitoring plan.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average
Activity Number of records per Total Annual burden per Total hours
recordkeepers recordkeeper Records recordkeeping
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Documentation included in 88 1.5 132 4 528
comprehensive monitoring plan..
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection, we have made no
adjustments to our burden estimate. We estimate 88 sponsors will
develop 132 comprehensive monitoring plans in accordance with the
guidance. We believe the associated burden for each plan is
approximately 4 hours and includes the time necessary to develop, and
amend as appropriate, the monitoring plan.
Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26032 Filed 11-29-18; 8:45 am]
BILLING CODE 4164-01-P
